Відео

@@raviji2089 surely will do Thanks

the Permitted Daily Exposure (PDE) value for the same Active Pharmaceutical Ingredient (API) can differ when used for veterinary and human applications in the context of cleaning validation in pharmaceuticals. You can use same formula, but ask toxicologist to provide PDE as per Veterinary. Even PDE value differ for each root of administration like, oral , injectable, dermal, Nasal spray etc

Please tell me any specific expectations

Yes started. uploaded one video on Punches and dies

@@abuuhhemedy2077 for New facility also you have to follow the same procedure only thing is initially you may not have many molecules. You can continue with swab and rinse testing. After few days or after manufacturing sufficient products you can proceed for cleaning validation

@@dhirendrakumar9361 on which topic

Thank you for being the first to comment!

Sir It's a life changing book for Personal & work life change management ❤ Thank you sir for Live training 😍 Change my perspective of Dealing life & work management.😊

@amardhane2222 thanks Amar

@@somnathbandgar626 thanks

As per USFDA DWPE (Detention Without Physical Examination) is a regulatory tool used to prevent the importation of products that appear to violate U.S. laws or regulations, typically related to safety, labeling, or manufacturing standards. Key Points About DWPE: 1. Automatic Detention: Products subject to DWPE are automatically detained at the port of entry without physical examination. FDA Import Alerts: DWPE is often tied to Import Alerts, which list products, manufacturers, or shippers that are subject to this detention policy. 2. Common Reasons for DWPE: o Non-compliance with Good Manufacturing Practices (GMP). o Microbial contamination (e.g., Salmonella in food products). o Presence of banned substances in food, drugs, or cosmetics. o Misbranding or inadequate labeling. o Mislabeling, or evidence of adulteration or have a history of non-compliance or are suspected to be non-compliant 3. Removal from DWPE: To be removed from a DWPE list, manufacturers must demonstrate that corrective actions have been implemented and provide evidence of sustained compliance. 4. Release Process: o Importers must provide evidence to demonstrate that their detained product complies with U.S. laws and regulations to secure its release. This typically involves submitting laboratory test results or documentation verifying compliance. o If compliance is proven, the product can be released; otherwise, it is refused entry into the U.S. and may need to be destroyed or exported. For further details, please search the FDA’s Import Alert database.

@@Vinaysingh-fm5is noted will do

@@01santy Thank you

Thank you

Thank you

😊

My pleasure!

@@official_sanjeev8765 WHo TRS 961, ANNEX 5 REFER 4.1.6

Yes sure

to ensure that the equipment is clean and free of contamination before the study begins. And understand trend if it was not free from RS.

20 November 2014 EMA/CHMP/ CVMP/ SWP/169430/2012 Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

WHO TRS 1033 Annex 2

Ohh you are right it's typo error from my side. Thank you for correcting and sorry for inconvenience.

@@mayurkale5357 No. In new approach safety factor is removed from MACO calculation.

Sir PDE ki calculation bi bata dy plz

@waqarking6801 ok will do small video on this

@@sandipmali1273 thank you

Ok sure

@@AshaDorage it's general purpose media which supports growth of all type of Microbes

Thanks

Thank you

It's my pleasure

ua-cam.com/video/6-TSSBRcU-A/v-deo.htmlsi=nv9fkmAim9-_03gd

Refer this link

Thank you. Yes sure

Yes sure Thank you for your support

Will do one video on Batch record presentation and review

Ok noted

@@RaviGupta-tl3hrthank you for your comment